Development and Validation of an in-line API Quantification Method Using AQbD Principles Based on UV-Vis Spectroscopy to Monitor and Optimise Continuous Hot Melt Extrusion Process

• Auteurs principaux: Juan Almeida (Auteur), Mariana Bezerra (Auteur), Daniel Markl (Auteur), Andreas Berghaus (Auteur), Phil Borman (Auteur), Walkiria Schlindwein (Auteur)
• Format: Livre
• Publié: MDPI AG, 2020-02-01T00:00:00Z.
• Sujets: article
• Accès en ligne: Connect to this object online.

A key principle of developing a new medicine is that quality should be built in, with a thorough understanding of the product and the manufacturing process supported by appropriate process controls. Quality by design principles that have been established for the development of drug products/substanc...